FDA Adverse Event Other Summary report: N

OPTIFLEX III CRM

MDR report key: 1743186 · Received June 28, 2010

Report

Report Number: 1022819-2010-00010
Event Type: Other
Date Received: June 28, 2010
Date of Event: April 20, 2010
Report Date: June 28, 2010
Manufacturer: CHATTANOOGA GROUP
Product Code: BXB
PMA / PMN Number: K841674
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UNIT FAILED INITIAL ELECTRICAL SAFETY TESTING. THE IEC CONNECTOR WAS PULLED OUT OF ITS RECEPTACLE. IT APPEARED TO HAVE BEEN PHYSICALLY PULLED OUT OF THE ENCLOSURE. THE UNITS GROUNDING TESTED GOOD WITH ONLY .5 OHMS FROM FRAME TO PIN. NO POWER CORD WAS SUPPLIED SO I WAS UNABLE TO TEST. REPLACED THE IEC CONNECTOR BEFORE CONTINUING TO TEST THE UNIT AND THE UNIT PASSED. WHILE PERFORMING THE PRE BURN-IN TESTING IT WAS DISCOVERED THAT THE MOTOR HAD FAILED. IT WILL NEED TO BE REPLACED BEFORE THE UNIT WILL BE OPERATIONAL. CONCLUSION: THE UNITS IEC CONNECTOR FAILED TO REMAIN INTACT WHICH IS LIKELY THE CAUSE OF THE MOTOR FAILURE. IT LOOKED TO HAVE BEEN FORCEFULLY PULLED OUT. IF THE GROUND CONNECTOR MADE CONTACT WITH ONE OF THE POWER WIRES IT WOULD PRESENT A FIRE HAZARD. IT WILL NEED TO BE REPLACED BEFORE RETURNING TO THE CUSTOMER.

Description of Event or Problem · 1

CUSTOMER ((B)(6) REGIONAL MEDICAL CENTER) COMPLAINED THAT POWER CORD PLUG-IN ON UNIT PULLED OUT OF UNIT. THE UNIT WAS NOT IN USE AT THE TIME OF DISCOVERY. NO INJURY OCCURRED AND NO PATIENT WAS INVOLVED. DEVICE HAS MALFUNCTIONED AND THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTIFLEX III CRM		BXB	CHATTANOOGA GROUP	2090

Patients

Seq	Age	Sex	Outcome	Treatment
1